MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3532A; VITAL SIGNS MONITOR

Model Number	BSM-3532A
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/06/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer reported that one of their patients experienced a fatal rhythm that the bedside monitor (bsm) did not pick up.The ecg print out suggest a faster rate without a documented crisis alarm.The documentation also reveals a low mv for the patient hr.However, arrhythmia alarms did capture an "irregular rr".Additional device information: concomitant medical device: the following device was used in conjunction with the model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that one of their patients experienced a fatal rhythm that the bedside monitor (bsm) did not pick up.The ecg print out suggest a faster rate without a documented crisis alarm.The documentation also reveals a low mv for the patient hr.However, arrhythmia alarms did capture an "irregular rr".

• Brand Name: BSM-3532A
• Common Device Name: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 13170621
• Report Number: 2080783-2022-02273
• Device Sequence Number: 11878443
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/05/2022
• Report Date (Section F): 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BSM-3532A
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2021
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL NURSE'S STATION (CNS)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/05/2022